Minerva Neurosciences, Inc., a clinical-stage biopharmaceutical company, focuses on the development and commercialization of product candidates for the treatment of central nervous system diseases. Its lead product candidate is roluperidone, a compound in Phase III clinical trial for the treatment of schizophrenia; and MIN-301, a soluble recombinant form of the neuregulin-1b1 protein for the treatment of Parkinson's disease and other neurodegenerative disorders. Minerva Neurosciences, Inc. has a license agreement with Mitsubishi Tanabe Pharma Corporation to develop, sell, and import roluperidone globally excluding Asia. The company was formerly known as Cyrenaic Pharmaceuticals, Inc. and changed its name to Minerva Neurosciences, Inc. in 2013. Minerva Neurosciences, Inc. was incorporated in 2007 and is headquartered in Waltham, Massachusetts.
IPO Year: 2014
Exchange: NASDAQ
Website: minervaneurosciences.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 3/4/2022 | $10.00 → $5.00 | Buy | HC Wainwright & Co. |
4 - Minerva Neurosciences, Inc. (0001598646) (Issuer)
4 - Minerva Neurosciences, Inc. (0001598646) (Issuer)
4 - Minerva Neurosciences, Inc. (0001598646) (Issuer)
4 - Minerva Neurosciences, Inc. (0001598646) (Issuer)
4 - Minerva Neurosciences, Inc. (0001598646) (Issuer)
4 - Minerva Neurosciences, Inc. (0001598646) (Issuer)
4 - Minerva Neurosciences, Inc. (0001598646) (Issuer)
4 - Minerva Neurosciences, Inc. (0001598646) (Issuer)
3 - Minerva Neurosciences, Inc. (0001598646) (Issuer)
4 - Minerva Neurosciences, Inc. (0001598646) (Issuer)
HC Wainwright & Co. reiterated coverage of Minerva Neurosciences with a rating of Buy and set a new price target of $5.00 from $10.00 previously
Frederick Ahlholm is Named Chief Financial Officer as Company Prepares to Submit a Pre-NDA Meeting Request to FDA WALTHAM, Mass., Oct. 11, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that Geoff Race, current Executive Vice President, Chief Financial Officer and Chief Business Officer of Minerva, has been promoted to President. Minerva's Senior Vice President and Chief Accounting Officer, Frederick Ahlholm, has been promoted to Chief Financial Officer. The appointments are effective immediately. These latest leadership
WALTHAM, Mass., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced Dr. Jay Saoud's retirement and transition to an advisory role and Dr. Ramana Kuchibhatla's appointment as Senior Vice President and Head of Research & Development, both effective September 16, 2021. Dr. Kuchibhatla will report directly to Dr. Remy Luthringer, Executive Chairman and Chief Executive Officer of Minerva. "I would like to thank Jay for the invaluable skill and leadership which have enabled Minerva to take roluperidone from early stage cl
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HC Wainwright & Co. analyst Douglas Tsao maintains Minerva Neurosciences (NASDAQ:NERV) with a Neutral and lowers the price target from $11 to $7.
Minerva Neurosciences (NASDAQ:NERV) reported quarterly losses of $(1.13) per share which beat the analyst consensus estimate of $(1.20) by 5.83 percent. This is a 13.74 percent increase over losses of $(1.31) per share from the same period last year.
-SEC Filing
U.S. stocks traded mixed toward the end of trading, with the Dow Jones index falling more than 100 points on Tuesday. The Dow traded down 0.35% to 38,932.26 while the NASDAQ rose 0.28% to 16,021.41. The S&P 500 also rose, gaining, 0.04% to 5,071.40. Check This Out: Wall Street's Most Accurate Analysts' Views On 3 Risk Off Stocks With Over 5% Dividend Yields Leading and Lagging Sectors Utilities shares rose by 1.2% on Tuesday. In trading on Tuesday, energy shares fell by 0.4%. Top Headline The J.M. Smucker Company (NYSE:SJM) posted better-than-expected earnings for its fourth quarter on Tuesday. The company reported third-quarter adjusted earnings per share of $2.48, bea
Minerva Neurosciences Inc (NASDAQ:NERV) shares are trading lower after the FDA issued a Complete Response Letter (CRL) to the company’s marketing application for roluperidone for the treatment of negative symptoms in patients with schizophrenia. In the CRL, the FDA cited the following clinical deficiencies: Although one study (MIN-101C03) demonstrated statistical significance on the primary efficacy endpoint, it is insufficient on its own to establish substantial evidence of effectiveness. The application submission lacks data on concomitant antipsychotic administration. The NDA submission lacks the data needed to establish that the change in negative symptoms of schizophrenia
HC Wainwright & Co. analyst Douglas Tsao reiterates Minerva Neurosciences (NASDAQ:NERV) with a Neutral and maintains $11 price target.
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U.S. stocks traded mixed midway through trading, with the Dow Jones index falling around 150 points on Tuesday. The Dow traded down 0.39% to 38,915.65 while the NASDAQ rose 0.15% to 15,999.50. The S&P 500 also fell, dropping, 0.03% to 5,067.80. Check This Out: Wall Street's Most Accurate Analysts' Views On 3 Risk Off Stocks With Over 5% Dividend Yields Leading and Lagging Sectors Utilities shares rose by 1.5% on Tuesday. In trading on Tuesday, energy shares fell by 0.5%. Top Headline Macy’s Inc (NYSE:M) reported mixed quarterly results and announced plans to close 150 stores. The company reported fourth-quarter adjusted EPS of $2.45, beating the analyst consensus of $1.
U.S. stocks traded mixed this morning, with the Nasdaq Composite gaining around 50 points on Tuesday. Following the market opening Tuesday, the Dow traded down 0.07% to 39,043.13 while the NASDAQ rose 0.31% to 16,026.43. The S&P 500 also rose, gaining, 0.10% to 5,074.75. Check This Out: Wall Street's Most Accurate Analysts' Views On 3 Risk Off Stocks With Over 5% Dividend Yields Leading and Lagging Sectors Utilities shares rose by 0.7% on Tuesday. In trading on Tuesday, health care shares fell by 0.3%. Top Headline Lowe’s Companies Inc (NYSE:LOW) posted better-than-expected fourth-quarter results. Lowe’s reported fourth-quarter FY23 sales of $18.60 billion, beating the
BURLINGTON, Mass., May 15, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported business updates and financial results for the first quarter ended March 31, 2023. "The first quarter saw the achievement of a significant milestone for our investigational drug, roluperidone, and for Minerva, as the U.S. Food and Drug Administration (FDA) filed our New Drug Application (NDA) for roluperidone for the treatment of negative symptoms of schizophrenia on April 27, 2023. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of
BURLINGTON, Mass., May 08, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that it will release first quarter 2023 financial results and business updates on Monday, May 15, 2023. The Company will host a webcast that day at 8:30 a.m. Eastern Time to discuss the results and updates. The live conference call may be accessed here and on the Company's website under Events and Presentations. The archived webcast will be available on the Company's website beginning approximately two hours after the event for 90 days. About Miner
BURLINGTON, Mass., March 08, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported business updates and financial results for the fourth quarter and year ended December 31, 2022. Corporate Update "In 2022, we had multiple interactions with the FDA regarding the regulatory path forward for our lead compound, roluperidone. After submitting an NDA for roluperidone to the FDA in August, we received a Refuse to File letter (RTF) in the fall, which was upheld following another meeting with the FDA. We remain committed to developing roluperid
BURLINGTON, Mass., March 01, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that it will release fiscal year 2022 financial results and business updates on Wednesday, March 8, 2023. The Company will host a webcast that day at 8:30 a.m. Eastern Time to discuss the results and updates. The live conference call may be accessed here and on the Company's website under Events and Presentations. The archived webcast will be available on the Company's website beginning approximately two hours after the event for 90 days. About M
BURLINGTON, Mass., Nov. 09, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today reported key business updates and financial results for the quarter ended September 30, 2022. Roluperidone Update As announced on August 17, 2022, the company submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application (NDA) for roluperidone to treat negative symptoms in schizophrenia. The submission included data from two clinical trials, the company's phase 2b and phase 3 studies, in patients diagnosed with schizophrenia with negative sy
BURLINGTON, Mass., Nov. 02, 2022 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that it will release financial results and business updates for the third quarter of 2022 on Wednesday, November 9, 2022. The Company will host a webcast that day at 8:30 a.m. Eastern Time to discuss the results and updates. The live conference call may be accessed here and the webcast is available on the Company's website under Events and Presentations. The archived webcast will be available on the Company's website beginning approximately two
Company to Host Conference Call Today at 8:30 a.m. ET WALTHAM, Mass., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today reported key business updates and financial results for the quarter ended September 30, 2021. Roluperidone Update On November 3, 2021, the Company announced that the U. S. Food and Drug Administration (FDA) denied the company's request for a pre-NDA meeting for roluperidone and responded that a Type C guidance meeting would be more appropriate to discuss the evidence for use of roluperido
WALTHAM, Mass., Nov. 01, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that it will release financial results and business updates for the third quarter of 2021 on Monday, November 8, 2021. The Company will host a webcast and conference call that day at 8:30 a.m. Eastern Time to discuss these results and updates. The live call may be accessed by dialing (877) 312-5845 (US and Canada) or (765) 507-2618 (international) and referring to conference ID number 3775536. The live webcast of the conference call can also be accesse
WALTHAM, Mass., Aug. 02, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today reported key business updates and financial results for the quarter ended June 30, 2021. Roluperidone Update Following the completion of the open-label portion of the Phase 3 trial with roluperidone in schizophrenia and the Type C meeting with the U.S. Food and Drug Administration (FDA), the Company continues to work towards the submission of a New Drug Application (NDA) in the first half of 2022. On June 29, 2021, the Company completed the enrollment of 48 su
WALTHAM, Mass., July 26, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that it will release financial results and business updates for the second quarter of 2021 on Monday, August 2, 2021. The Company will host a webcast and conference call that day at 8:30 a.m. Eastern Time to discuss these results and updates. The live call may be accessed by dialing (877) 312-5845 (domestic) or (765) 507-2618 (international) and referring to conference ID number 4327209. A live webcast of the conference call will be available online in
BURLINGTON, Mass., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today reported business updates and financial results for the third quarter of 2024 ending September 30, 2024. Roluperidone NDA Update As announced in February 2024, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to our New Drug Application (NDA) for roluperidone (f/k/a MIN-101) for the treatment of negative symptoms in patients with schizophrenia. Interactions with the FDA continue with the goal of addressing questions rais
BURLINGTON, Mass., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today reported business updates and financial results for the second quarter of 2024 ending June 30, 2024. Roluperidone NDA Update During the first quarter of this year, the Company announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to its New Drug Application (NDA) for roluperidone (f/k/a MIN-101) for the treatment of negative symptoms in patients with schizophrenia. Since receiving the CRL, the Company has cont
BURLINGTON, Mass., May 01, 2024 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today reported business updates and financial results for the first quarter of 2024 ending March 31, 2024. Roluperidone NDA Update On February 27, 2024, the Company announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to its New Drug Application (NDA) for roluperidone (f/k/a MIN-101) for the treatment of negative symptoms in patients with schizophrenia. The Company is in discussions with the FDA regarding the issues and
BURLINGTON, Mass., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the Company's New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia. In the CRL, the FDA cited the following clinical deficiencies: Although one study (MIN-101C03) demonstrated statistical significance on the primary efficacy endpoint, it is insufficient on its own to establish substantial evidenc
BURLINGTON, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported business updates and financial results for the third quarter ended September 30, 2023. The Company continues to work with the U.S. Food and Drug Administration (FDA) during its review of its New Drug Application (NDA) for roluperidone for the treatment of negative symptoms of schizophrenia, in advance of the February 26, 2024 PDUFA date. "We remain committed to bringing roluperidone to patients and physicians as we believe it addresses a significant un
BURLINGTON, Mass., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported business updates and financial results for the second quarter ended June 30, 2023. "In the second quarter, we completed an equity financing of $20.0 million, further strengthening our cash position. This investment from Boehringer Ingelheim and Federated Hermes Kaufman Funds comes as we continue to interact with the FDA in support of their review of our New Drug Application (NDA) for roluperidone for the treatment of negative symptoms of schizophren
BURLINGTON, Mass., June 28, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today announced that it has agreed to sell an aggregate of 1,425,000 shares of its common stock at a purchase price of $10 per share and pre-funded warrants to purchase an aggregate of 575,575 shares of its common stock at a purchase price of $9.99 per pre-funded warrant, to Boehringer Ingelheim, a global biopharmaceutical company with a growing mental health pipeline that includes schizophrenia, and Federated Hermes Kaufmann Funds in a private investment in public equity
BURLINGTON, Mass., May 15, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported business updates and financial results for the first quarter ended March 31, 2023. "The first quarter saw the achievement of a significant milestone for our investigational drug, roluperidone, and for Minerva, as the U.S. Food and Drug Administration (FDA) filed our New Drug Application (NDA) for roluperidone for the treatment of negative symptoms of schizophrenia on April 27, 2023. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of
FDA confirms acceptance of the filing of the NDA for roluperidone Application has been granted a standard review FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 26, 2024 BURLINGTON, Mass., May 10, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that on May 8, 2023, it received confirmation from the U.S. Food and Drug Administration (FDA) that the Company's New Drug Application (NDA) for roluperidone for the treatment of negative symptoms in patients with schizophrenia has been filed in acc
BURLINGTON, Mass., May 08, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that it will release first quarter 2023 financial results and business updates on Monday, May 15, 2023. The Company will host a webcast that day at 8:30 a.m. Eastern Time to discuss the results and updates. The live conference call may be accessed here and on the Company's website under Events and Presentations. The archived webcast will be available on the Company's website beginning approximately two hours after the event for 90 days. About Miner
10-Q - Minerva Neurosciences, Inc. (0001598646) (Filer)
DEFA14A - Minerva Neurosciences, Inc. (0001598646) (Filer)
DEF 14A - Minerva Neurosciences, Inc. (0001598646) (Filer)
8-K - Minerva Neurosciences, Inc. (0001598646) (Filer)
8-K - Minerva Neurosciences, Inc. (0001598646) (Filer)
10-Q - Minerva Neurosciences, Inc. (0001598646) (Filer)
8-K - Minerva Neurosciences, Inc. (0001598646) (Filer)
10-Q - Minerva Neurosciences, Inc. (0001598646) (Filer)
10-K/A - Minerva Neurosciences, Inc. (0001598646) (Filer)
8-K - Minerva Neurosciences, Inc. (0001598646) (Filer)